DUBLIN–(BUSINESS WIRE)–The “FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control” webinar has been added to ResearchAndMarkets.com’s offering.
This session will equip you with the knowledge and comprehensive understanding of FDA requirements for Out-of-Trend Results in pharmaceutical quality control.
FDA’s guidance on OOS test results requires failure investigations and other steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results. While most companies are familiar with and have procedures for OOS results, this is not the case for OOT situations.
The guide states: `Although the subject of this document is OOS results, much of the guidance may be useful for examining results that are out of trend`. Managing OOT results also helps to avoid time consuming OOS results. The industry is unsure how to interpret and implement the FDA guidance.
Key Topics Covered:
- FDA regulations and guidelines.
- FDA’s final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
- Difference between OOS and OOT results.
- Developing SOPs for OOT situations and laboratory failures.
- Investigating OOT results: what and how.
- Retesting of OOT results.
- Using historical data for OOT evaluation.
- Using QC samples and product control charts for evaluation.
- Developing corrective and preventive action plans.
- Finding the root cause for OOT results.
- Strategies to avoid OOS situations BEFORE they occur.
- FDA compliant documentation of OOS, OOT, failure investigations, root causes and CAPA.
Who Should Attend:
- Analysts
- Lab Supervisors and Managers
- QA managers and personnel
- Pharmaceutical R&D personnel
- Documentation
- Consultants
- Contract laboratories
- CROs
For more information about this webinar visit https://www.researchandmarkets.com/r/jio2fj
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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